Investigation of the safety and efficacy of human growth hormone replacement therapy in adults in relation to diagnostic criteria and different dosage algorithms

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000446662

Enrollment

600

Registered

2005-09-21

Start date

1997-01-04

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary aim was to determine whether a lower dose of GH is as effective as higher doses at increasing lean body mass and whether GH-related side-effects are reduced with a lower dose.

Interventions

GH replacement at 3 different doses for 6 months.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Adults with GH deficiency.

Exclusion criteria

Significant pulmonary, cardiac, hepatic or renal disease or cancer.

Outcome results